Randstad Clinical Operations in Durham, North Carolina
Wednesday, October 12, 2016
Randstad Life Sciences
Job Title: TMF Specialist Project Leader
Support global standards for Records Management activities.
Actively support activities associated with managing records within a global network of programs/systems for customers Trial Master File documents.
Serve as the liaison between Records Management and customers.
Supporting functional operational teams adhere to GCP records management and customer specific requirements, providing oversight of TMF management and developing a collaborative delivery of a quality TMF for our customers.
Act as an SME for the file management process & all RIM Global management activities
Serve as TMF contact for documentation to Project team, cross functional departments to ensure high quality TMF deliverables are met on time.
Follow processes for set up, maintenance, and support for assigned TMF projects.
Monitor TMF throughout the study duration, identify and record quality problems, suggest, initiate, recommend or provide solutions as appropriate.
Report TMF metrics trending and analysis as appropriate with resolution plans to proactively identify & avoid future issues
Facilitate collecting, processing and disposition of various project-related records for paper & electronic documents to sponsor
Follow applicable SOP s to ensure completeness & accuracy of TMF
Prepare/present TMF related information at internal meetings in a Globally consistent format
Provide support & involvement with internal quality or audit process s as relevant
Accountable for delivery of assigned TMF activities in accordance with project requirements & SLA s
Manage documentation associated with assigned clinical trials
Follow records management tasks, policies, and procedures
Conduct review documents with compliance to customer file plans and SOPs
SME on all designated Sponsor-specific TMF requirements (e.g. file format, process, export/shipping requirements)
Collaborates on TMF Quality for assigned sponsor trials
Reports TMF health findings at required frequency
Alert Project team and TMF Quality PM to any potential TMF Health issues
Provide regular updates on performance to SLAs
Bachelor s degree and 3 years of related experience or equivalent combination of education, training and experience
In Depth/ Knowledge of and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Working knowledge of regulations and guidance s relevant to the area of expertise
Knowledge of technology applications relevant to records management environments.
Strong software and computer skills, including MS Office applications.
Ability to establish and maintain effective working relationships with coworkers, managers,
Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
Excellent communication, presentation and interpersonal skills
Good problem solving skills
An ability to demonstrate a critical eye & strong attention to detail
Ability to adapt quickly to a rapidly changing environment
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance